The TGA has proposed new classification rules for software based medical devices, including smart phone apps. This means that classification rules are now based on risk to individual or public health rather than the intended purpose. In summary, very few software based devices will be class I. Transition periods apply for those currently ARTG entered, otherwise new rules apply Feb 2021. SPEAK TO US TODAY for further information Contact us on: @ [email protected] 0433124266

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Australian TGA Sponsor for[…]

As per the Australian TGA Medical Device Regulations, before someone can supply a Medical device for sale in Australia they are required to make an application to include the item in the Australian Register Therapeutic Goods (ARTG). The sponsor is the person or company responsible for the importation of therapeutic goods into Australia. If you are an overseas manufacturer of medical devices and you require Australian ARTG entry, let Compliance Management Solutions act as your sponsor. We aim to provide our customers with the highest level of service with an efficient and cost effective approach. About CMS: CMS is a service provider for the following: Therapeutic Goods: Australian TGA Sponsor for[…]

GOODBYE GMDN………………….HELLO EMDN The EMDN will be the nomenclature used when registering medical devices In the Eudamed database. Although mapped to the current GMDN Nomenclature, it is stand alone and will be used in future as a searching tool by EU Operators. SPEAK TO US TODAY George Loizou | Director | MDD/MDSAP/MDR Notified Body/AO Lead Auditor | MDD/MDR Notified Body Technical File Reviewer | Contact us on: C | M | S – Compliance Management Solutions – Leaders In Compliance (Australia, Europe, Vietnam, Singapore, Malaysia, NZ) M: +61 4 33 124266 W: compliancems.com.au E: [email protected]  Kew, Victoria

Medical Device Single Audit Program (MDSAP), TGA, MDD, IVDD, MDR, IVDR and more……………………………… Achieve access to multiple markets with a single audit The International Medical Device Regulators Forum (IMDRF) established a working group to develop a standard set of requirements for auditing organizations (Certification Bodies) performing regulatory audits of Medical Device manufacturers’ quality management systems. Termed the Medical Device Single Audit Program (MDSAP), the requirements will be applicable to regulatory authorities, as well as third-party organizations that conduct such audits. What is MDSAP? The objective of the MDSAP is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a Medical Device manufacturer,[…]